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Completed

NCT Number: NCT01626053

The Efficacy and Treatment Adherence With an Integrated Program on HbA1c Scores in Patients With Type 2 Diabetes

It is hypothesized for this study that the coupling of the Millon Behavioral Medicine Diagnostic, biopsychosocial evaluation, motivational interviewing, relapse prevention, and ongoing support can produce improved outcomes with diabetics who have previously been unsuccessful with the traditional care. This study examined the relationship between patients' HbA1c levels and patients' involvement in the ASMART program, a multifaceted program involving psychological intervention. The study was conducted through the Kosciusko Health Department and funded by K21 Health Foundation.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northern Lakes Medicine

Warsaw, Indiana, 46580, United States

About this study

The study involved 182 Type 2 Diabetes patients with an HbA1c score above 7, reflecting poor control of diabetes. The experimental group consisted of 124 patients who joined the ASMART program, while the control group consisted of 60 patients who continued to receive traditional care. Statistical analysis involved comparing pretest & posttest HbA1c levels for the experimental group and the control group.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Type 2 Diabetes patients with an HbA1c score over 7

Exclusion criteria

  • No Type 1 patients
  • No children under the age of 18

Treatment and study plan

ASMART

Behavioral

Motivational Interviewing, Stages of Change, Psychological Testing, Bio-psychosocial assessment, responsive diabetes education, support, Cognitive-behavioral interventions

Control Group

Other

no intervention

Primary outcomes

  1. Changes in A1c levels for pretest and post test (Preset baseline and post-test 2 years

    Time frame: Pretest / posttest

    Statistical analysis involved comparing pretest and psttest HbA1c levels for the experimental group and the control group

Sponsors and collaborators

Lead sponsor

KRJG Services Inc.

Other

Collaborators

  • K21 Health Foundation
  • Kosciusko County Health Department

Registry information

Acronym: ASMART

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jun 22, 2012
Registry last updated
Jun 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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